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Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > IEC 60601 - Medical Electrical Equipment Safety Standards Series
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EN 55011:1998 +A1:1999 +A2:2002 vs. EN55011:2009 Test Levels - Medical Devices

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class i medical device, en 55011, medical devices (general)
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  #1  
Old 19th February 2010, 01:07 PM
qu1nn

 
 
Posts: 33
Please Help! EN 55011:1998 +A1:1999 +A2:2002 vs. EN55011:2009 Test Levels - Medical Devices

Hello,

Is there any change in the test levels from EN 55011:1998 +A1:1999 +A2:2002 to EN55011:2009 which would require re-testing for a Group 1 Class B Medical Device?

Thanks for your time
qu1nn

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  #2  
Old 20th February 2010, 04:23 AM
Stijloor's Avatar
Stijloor

 
 
Posts: 14,651
Re: EN 55011:1998 +A1:1999 +A2:2002 vs. EN55011:2009 Test Levels - Medical Devices

Quote:
In Reply to Parent Post by qu1nn View Post

Hello,

Is there any change in the test levels from EN 55011:1998 +A1:1999 +A2:2002 to EN55011:2009 which would require re-testing for a Group 1 Class B Medical Device?

Thanks for your time
qu1nn
Can anyone help?

Thank you very much.

Stijloor.
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  #3  
Old 22nd February 2010, 07:36 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Posts: 2,501
Re: EN 55011:1998 +A1:1999 +A2:2002 vs. EN55011:2009 Test Levels - Medical Devices

I´m just giving another bump here. Althougu there´s seem to be only a few medical device EMC experts here on the Cove, they do exist, but might take a while to answer.

Just to make things clear, EN 55011 is the european version of CISPR 11 which is used as a normative reference in IEC 60601-1-2, right?
  #4  
Old 22nd February 2010, 10:05 AM
nikolaos

 
 
Posts: 76
Re: EN 55011:1998 +A1:1999 +A2:2002 vs. EN55011:2009 Test Levels - Medical Devices

Quote:
In Reply to Parent Post by qu1nn View Post

Hello,

Is there any change in the test levels from EN 55011:1998 +A1:1999 +A2:2002 to EN55011:2009 which would require re-testing for a Group 1 Class B Medical Device?

Thanks for your time
qu1nn
EN 55011 is the European edition of CISPR 11.
The EN 55011:2009 is not listed in the Ofiicial Journal of the European Union yet. This version is identical with the ed. 5 of CISPR 11(2009-05).


There is no difference between the old CISPR 11 / EN 55011 and the new for your type of equipment, no re-test necessary.

  #5  
Old 26th January 2011, 03:29 PM
qu1nn

 
 
Posts: 33
Re: EN 55011:1998 +A1:1999 +A2:2002 vs. EN55011:2009 Test Levels - Medical Devices

Maybe I am just slow, but I am continuously struggling with the language of the Europa site with expiration dates of specifications. So can someone confirm if I am looking at the dates incorrectly for the EN 55011

from this site:


I am seeing the following:

Specification, Expires on
EN 55011:1998 + A1:1999 +A2:2002, expires Nov 1, 2009
EN 55011:2007, expires Sept 1, 2012
EN 55011:2007 + A2:2007, expires Sept 1, 2012
EN 55011:2009 expires, July 1, 2013
EN 55011:2009 + A1:2010, unknown expiration



Thanks for your time
qu1nn
  #6  
Old 27th January 2011, 04:21 AM
Pads38

 
 
Posts: 520
Re: EN 55011:1998 +A1:1999 +A2:2002 vs. EN55011:2009 Test Levels - Medical Devices

The 'Normative' reference in EN60601-1-2:2007 is an undated reference to CISPR 11 - that means the latest version of CISPR 11 is the one to use.
  #7  
Old 12th October 2011, 03:52 PM
jradford

 
 
Posts: 49
Re: EN 55011:1998 +A1:1999 +A2:2002 vs. EN55011:2009 Test Levels - Medical Devices

What is the relationship between IEC60601-1-2 and EN55011?
  #8  
Old 12th October 2011, 10:48 PM
raymond02302

 
 
Posts: 61
Re: EN 55011:1998 +A1:1999 +A2:2002 vs. EN55011:2009 Test Levels - Medical Devices

EN 55011 (CISPR 11) is a reference standard for EN 60601-1-2 (IEC 60601-1-2) for emission test, there are also other reference standards for EN 60601-1-2 (IEC 60601-1-2) for emission test , such as EN 55015 (CIRPR 15), EN 55014-1 (CISPR 14-1) and EN 55022 (CISPR 22). User of EN 60601-1-2 (IEC 60601-1-2) should indendify which standard to follow depending on the technique used by EUT.
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